Safety Study of Univers® Revers Shoulder Prosthesis

NCT01778777 | Completed DMC

• 1 other identifier: UniversRevers
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%. Such adverse events include (but are not limited to) revisions due to dislocation or glenoid loosening, septic arthritis and scapular fractures requiring surgical repair.

Conditions

Rotator Cuff Tear Arthropathy

Keywords

rotator cuff tear arthropathy; inverse prosthesis; safety; universe reverse

Outcome Measures

Primary Outcomes (1)

• SADE within 2 years po

  The primary safety objective is to demonstrate that severe device-related complication (Serious Adverse Device Effect = SADE) occur within 2 years after prosthesis implantation at a rate of less than 2%.

  2 years po

Secondary Outcomes (9)

• Risk of adverse events intra-operatively, and post-operatively up to 2 years follow-up

  2 years

• Prosthesis survival at 2, 5 and 10 years

  2, 5 and 10 years

• Constant (Murley) score (CS)

  6mo, 1, 2, 5 and 10 years

• The Shoulder Pain and Disability Index (SPADI)

  6mo, 1, 2, 5 and 10 years

• Short version of the Disability of the Arm, Shoulder and Hand questionnaire (QuickDASH)

  6mo, 1, 2, 5 and 10 years

Study Arms (1)

UniverseReverse

EXPERIMENTAL

Cohort get an universe reverse prosthesis

Device: Universe Reverse Prosthesis

Interventions

Universe Reverse Prosthesis DEVICE

Implantation of an universe reverse prosthesis

UniverseReverse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18 years and over
• Patient with primary omarthrosis or secondary osteoarthritis associated with insufficiency in the centering function of the rotator cuff
• and
• Willing and able to give written informed consent to participate in the study including all follow-up examinations

You may not qualify if:

• Previous ipsilateral shoulder arthroplasty
• Acute shoulder trauma
• Post-traumatic secondary osteoarthritis
• Rheumatoid arthritis
• General medical contraindication to surgery
• Known hypersensitivity to the materials used
• Tumour / malignoma
• Any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder)
• Bacterial infection at the time point of operation
• Recent history of substance abuse
• Legal incompetence
• Pregnancy or
• Participation in any other medical device or medicinal product study within the previous months that could influence the results of the present study

Sponsors & Collaborators

• Schulthess Klinik: lead
• Arthrex, Inc.: collaborator

Study Sites (1)

Schulthess Klinik

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Study Officials

• Hans-Kaspar Schwyzer, Dr.

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 29, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: April 15, 2023
• Last Updated: April 18, 2023

Record last verified: 2022-05

Locations

CH (1)